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Acorda shares drop after FDA issues letter

March
31

Shares of Hawthorne-based Acorda Therapeutics fell 19 percent this morning after federal regulators refused to accept the company’s application for Fampridine-SR, a drug for people with multiple sclerosis.

The company said the Food and Drug Administration issued a “refuse to file” letter for the drug, which would help people with multiple sclerlosis walk. The FDA has “format issues” with the company’s electronic submission. The company said the FDA wants some of the data put into a different format and also requested some additional information.

“We are surprised by this development,” Dr. Ron Cohen, the company’s president and chief executive, said in a statement released by the company. “We plan to address the issues raised in this letter with (the) FDA expeditiously, as we believe Fampridine-SR is potentially an important, first-in-class treatment option for people suffering with MS.”

Acorda shares were trading at $20.13, down $4.77 or 19.16 percent at 10 a.m.

This entry was posted on Tuesday, March 31st, 2009 at 9:25 am by Mike Bieger. You can follow any responses to this entry through the RSS 2.0 feed.
Category: Biopharmaceutical

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Business in the Burbs is our online news blog about businesses based or operating in the Lower Hudson Valley. Visitors here will also find items of interest to consumers in the region. Most contributions are from business reporters and editors covering Westchester, Rockland and Putnam counties.

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